Health Personnel, Induced Abortion, Medical Abortion, Second Trimester Abortion
Conditions
Keywords
Midlevel provider
Brief summary
The purpose of the study is to determine the safety and effectiveness of second trimester medical abortion when provided by nurse midwives compared with physicians. The study sample will be obtained from Michu Clinic, affiliated with St Paul's hospital, in Addis Ababa.
Detailed description
About 10% of all abortions globally take place at or after 13 weeks gestation. Women seeking second-trimester abortion services are often the most vulnerable and socially disadvantaged population.Studies show the rate of second-trimester abortion procedures remains stable over time, even in high-access locations, confirming the ongoing need for accessibility to services in rural locations with limited access to care. In Ethiopia, second-trimester abortion services are widely available in Addis Ababa, making up a high proportion of the total number of abortions occurring each year in the country; however, access to accurate and reliable data is limited. The World Health Organization recommends that abortion can be provided at the lowest level of the healthcare system (WHO abortion guidelines). Training mid-level providers, such as midwives, nurses and other non-physician providers, to conduct second trimester aspiration abortions is proposed as a way to increase women's access to safe abortion procedures and has been highlighted by the WHO as an area in which rigorous research is needed (WHO task-sharing guidelines). The investigators seek to conduct a comparative study of patients undergoing second trimester medical abortion provided by either physicians or nurse midwives.
Interventions
PROCEDUREProvider type: Physicians
In this cohort, women will receive second trimester medical abortion care from physicians
PROCEDUREProvider type: Midlevel Providers
In this cohort, women will receive second trimester medical abortion care from midlevel providers.
Sponsors
St. Paul's Hospital Millennium Medical College, Addis Ababa, Ethiopia
Ipas
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
The investigators propose a randomized, controlled, non-inferiority study comparing management of medical abortion by either nurse midwives or physicians for women undergoing induced abortion at a gestational ages \> 13 weeks.
Eligibility
Sex/Gender
FEMALE
Age
16 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Willing and able to give consent for participation * Intrauterine pregnancy with confirmed gestational age \>13 weeks and \<20 weeks * Presenting for induced abortion at Michu Clinic * Speaker of Amharic or Oromo
Exclusion criteria
* Women unable to give consent for participation * Gestational age \<13 or \>20 weeks * Adolescents aged less than 16 years * Women with an allergy to or contraindications to mifepristone or misoprostol * Women with a history of more than one previous hysterotomy * Women seeking treatment for incomplete abortion, intrauterine fetal demise, or postabortion care * Women with chronic hypertension or adrenal failure * Women on chronic steroid treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to expulsion | Time (hours/minutes) from first dose of misoprostol until the fetus is expelled, up to 72 hours | Time to expulsion of fetus after medical abortion regimen initiated |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total number of misoprostol doses | Time (hours/minutes) from first dose of misoprostol until the fetus and placenta are expelled, up to 72 hours | Doses of misoprostol needed for completion of abortion |
| Need for ultrasound to confirm gestational age | At the time of eligibility for the abortion is assessed, need for confirmatory ultrasound recorded (up to 1 day) | Whether ultrasound was needed to estimate gestational age |
| Need for intervention by a physician | Assessed at the time of discharge and reflecting entire duration of hospitalization (up to 7 days) | whether any physician involvement was needed to manage the case (from nurse-led services) |
| Serious complications/ morbidity | Assessed at the time of discharge and reflecting entire duration of hospitalization (up to 7 days) | Whether the following complications occur while a patient is receiving abortion services: hemorrhage requiring transfusion, placental retention requiring removal, uterine rupture, fever/ signs of infection requiring antibiotic treatment. |
| Adverse events | up to 7 days after discharge | Whether adverse events occurred that required a return to the hospital after discharge from Michu clinic. |
Countries
Ethiopia
Outcome results
None listed